Two US regulatory wins for Keytruda, a first for cervical cancer
The US Food and Drug Administration (FDA) has awarded Merck & Co. (known as MSD outside North America) two additional indications for its anti-PD-1 immunotherapy Keytruda (pembrolizumab).
Keytruda is a humanised monoclonal antibody (mAb) designed to block PD-1 interactions between its ligands and PD-L2. The immunotherapy activates T lymphocytes that in turn may affect tumorous and healthy cells.
US regulatory authorisation for the treatment of patients with recurrent or metastatic cervical cancer whose tumour express PD-L-1, and for the treatment of refractory or relapsed primary mediastinal large B-cell lymphoma (PMBCL), adds to a list of previously FDA-approved indications, including the treatment of certain patients with metastatic melanoma, head and neck cancer, and refractory classical Hodgkin lymphoma.
A cervical cancer first
A Merck spokesperson told us Keytruda is the first anti-PD-1 therapy approved for previously treated patients with advanced cervical cancer.
“While the incidence of cervical cancer has declined in the United States over the past several decades due to advancements in preventive vaccines and treatment, there has remained a significant unmet need for people who are at higher risk of developing the disease or who are diagnosed at an advanced stage,” the spokesperson added.
The firm told us the price for Keytruda remains unchanged, but declined a request to comment on additional regulatory plans for the biologic.
Earlier this year, the firm announced plans to build a biologics facility in Swords, Ireland, to support production of its immuno-oncology portfolio, and in particular, Keytruda.